Catalog Number

4040-12

Brand Name

ADC®

Version/Model Number

4040-12

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

CAE

Product Code Name

Airway, Oropharyngeal, Anesthesiology

Public Device Record Key

2811bf19-9470-412b-a4d5-eb4c4c8db445

Public Version Date

July 23, 2019

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

00634782501976

Quantity per Package

50

Contains DI Package

00634782001988

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case